Vaginal bacterial flora is an important part of human-associated microbiome. The environment of the human vagina differs from that of other human body's compartments. Human vagina is populated by multiple distinct microorganisms adapted to the particular environment. It is believed that vaginal microflora is a dynamic microbial system prone to changes in its species composition due to various exogenous and endogenous influences. There is no single vaginal “core microbiome”, but rather a “space” of distinctly different microbial communities. Relative dynamics of vaginal communities is still largely unknown, due to the lack of extensive longitudinal studies. Profound change in the microbial composition may take place during menstrual cycles or antibiotic therapy.
Specific vaginal communities are tightly linked to bacterial vaginosis (BV). Microbial species populating these communities are designated as BV-associated bacteria (BVAB). Most of the BVAB are fastidious anaerobic bacteria which are difficult to culture or yet to be cultured. On the contrary, vaginal communities dominated by lactobacilli are frequently associated with the absence of BV clinical symptoms. Taxonomical complexities of these vaginal communities are difficult to ascertain because they are usually dominated by a single Lactobacillus species.
Scarce information exists as to whether there is a strong association of taxonomic groups of specific vaginal microflora that may define as valid markers for different vaginal microbial conditions. Little is known regarding the relative amounts of these specific bacteria in vaginal samples, thus rendering it difficult for the predictive assessment of vaginal microflora status. To the best of the present inventors' knowledge, there has been no correlation made between bacterial qPCR quantitative results and the clinical diagnosis of BV according to the Amsel criteria.
There is a continuing need in assessing the profile of vaginal microflora and how they correlate with the progression of bacterial vaginosis. The present invention cures the above-mentioned defects and provides a useful quantitative detection assay for a selected group of nine (9) bacterial species. Disclosed herein are the inventive embodiments describing a dynamic nature of vaginal microflora. The present assay utilizes real-time PCR assays to quantity four (4) Lactobacillus species, as well as Gardnerella vaginalis, Atopobium vaginae, Megasphaera Type 1, Megasphaera Type 2 and BVAB2.